Use of Track One Prioritized Examination for Pharmaceutical Patents.

This study examines the use of the Track One prioritized patent examination program by pharmaceutical manufacturers from 2011 to 2022.

Federal Trade Commission Actions on Prescription Drugs, 2000-2022.

Importance: The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested. Objective: To review FTC legal actions in the pharmaceutical market from 2000-2022. Evidence Review: Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents. Findings: From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023. Conclusions and Relevance: The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior.

Generic Drugs and the Struggle to Compete: The Role of Skinny Labels.

PURPOSE: The generic drug industry currently faces multiple, serious issues that threaten the US drug supply. So-called "skinny labels" are one of the few tools authorized by Congress to expedite entry into the market by generic competitors when the first patent for a brand's drug compound (only) expires. This article reviews the law on this expedited marketing pathway for generic competitors, as well as limitations on its use. METHODS: We examined the literature on patent protection of brand drugs, including the timelines for production of generic competitors. We also examined the law concerning skinny labels, including a recent decision of the US Federal Circuit Court that clearly articulates the guidelines concerning entry into the generic market, including labeling, marketing, and promotion. FINDINGS: Skinny labels that follow the regulations set forth in the Hatch-Waxman Act, including the necessary carve-out procedure for "methods of use" still protected by 1 or more active patents, do not infringe a brand drug's label. Furthermore, the skinny label does not induce or contribute to infringement merely because its label contains US Food and Drug Administration-required safety profile data-even when the data cross-reference superiority studies on still-patent protected methods of use elsewhere in the label. IMPLICATIONS: Generic drugs have become essential to the broad, general availability of clinical therapeutic agents. The Hatch-Waxman Act was intended to facilitate entry of generic competitors into the marketplace, and the skinny label is an important tool to accomplish that end. As long as the generic manufacturer follows the essential skinny-label rules, specifically including marketing the compound without promoting or advertising those methods of use still protected by ongoing patents, the law will not find induced or contributory infringement.

The impact of proposed price regulations on new patented medicine launches in Canada: a retrospective cohort study.

BACKGROUND: The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches. METHODS: We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012-2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012-2017) and after the proposed amendments were published ("uncertain period," 2018-2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately. RESULTS: We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the other-countries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US. INTERPRETATION: No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation.

Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

Cambodia has experienced exponential economic growth in recent years and is expected to graduate from least developed country (LDC) status within the next decade. Membership of the World Trade Organization (WTO) will require Cambodia to grant product and process patents for pharmaceuticals upon LDC graduation. This study aims to measure the impact of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the price of HIV and hepatitis C medicine in Cambodia once it graduates from LDC status and is obliged to make patents available for pharmaceutical products and processes. Using scenarios based on likely outcomes of accession to the TRIPS Agreement, it measures the impact on the price of the HIV treatment program and compares that impact with the hepatitis C treatment program. Graduation from LDC status would be expected to result in a modest increase in the cost of the antiretroviral (ARV) treatment program and very large increases in the cost of the direct acting antivirals (DAA) treatment program. If annual treatment budgets remain constant, patent protection could see 1,515 fewer people living with HIV able to access ARV treatment and 2,577 fewer people able to access DAA treatment (a drop in treatment coverage of 93%).

Paucity of intellectual property rights information in the US biologics system a decade after passage of the Biosimilars Act.

In this Policy Forum piece, Robin Feldman discusses how current legislation contributes to informational deficits around drug patents for biologic drugs in the United States.

Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

The rebirth of epitope-based patent claims.

BACKGROUND: Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers. OBJECTIVE: This article tries to explain the patentability issues related to epitope-based patent claims. METHODS: For this purpose, an overview is given on the respective legal provisions and court decisions. RESULTS: The study reveals that the respective patentability standards are constantly changed by courts and lawmakers. CONCLUSIONS: Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.

Patents on Risk Evaluation and Mitigation Strategies for Prescription Drugs and Generic Competition.

This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition.

International Tale on Gene Patents - between Medical and Legal Uncertainties / Cuento internacional sobre patentes genéticas: entre la incertidumbre médica y jurídica

This work is inspired by the international litigation chronicle of Myriad Genetics that remains of topical importance in the judicial and academic discourse regardless of the time that passed since. It discusses approaches of various jurisdictions to the problem of gene patenting as well as patenting of geneticdiagnostic testing. The article takes under scrutiny the judgments rendered in the U.S., Australia as well as the decisions by the European Patent Office and placesthem into interdisciplinary background of genetic science. The issue is significant, both theoretically and practically. Notwithstanding the expiration of patents that constituted the subject matter of the Myriad’s various lawsuits, the problem still remains currently relevant. Firstly, because the judgments in individual cases did not answer all the questions, but – in some way – only prepared a path for future decisions. Secondly, it is on account of new scientific breakthroughs in the area of human genetics. Consequently, the domain of genetic diagnostics is under continuous development and in the future may continue to reveal new scientific discoveries and (possibly) inventions. The lack of uniform and transparent rules in this field, and well-defined boundaries for potential monopolies constantly brings not only uncertainty for medical practitioners and scientists, but also real disadvantagesfor the patients. (AU)

Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempotranscurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones sobre el problema de las patentes de genes, así como de las patentes de pruebas de diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes que constituyeron el objeto de los diversos pleitos de Myriad, el problema siguesiendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos individuales no respondieron a todas las preguntas, sino que –en cierto modo– sólo prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevosavances científicos en el ámbito de la genética humana. En consecuencia, el ámbito del diagnóstico genético está en continuo desarrollo y en el futuro puede seguirrevelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta de normas uniformes y transparentes en este ámbito y de límites bien definidos para los monopolios potenciales no sólo genera constantemente incertidumbre para losmédicos y científicos, sino también desventajas reales para los pacientes. (AU)

Inovação tecnológica que o Brasil precisa

Patentes e monopólios podem dificultar enfrentamento à pandemia. O tema será debatido em live do Conselho Nacional de Saúde, na quarta-feira (15/07) A pandemia da covid-19 tem reforçado a importância da produção científica e tecnológica na compreensão da doença, seus efeitos e na busca de soluções. No Brasil, esse cenário expôs problemas estruturais. Como a dependência tecnológica e produtiva na área da Saúde e a disponibilidade de medicamentos, equipamentos e tecnologias, que podem sofrer restrições em função de patentes e monopólios. Para debater a situação do desenvolvimento tecnológico em Saúde no Brasil e os caminhos para ampliar o acesso às tecnologias, o Conselho Nacional de Saúde (CNS) vai realizar nesta quarta (15/07), às 17h, um encontro online transmitido pelo youtube e pelo facebook. Para falar sobre o tema, foram convidados o economista, professor e pesquisador da área de Desenvolvimento e Inovação em Saúde na Fundação Oswaldo Cruz (Fiocruz) do Rio de Janeiro, Carlos Gadelha, e o médico, doutor em Saúde Pública e pesquisador da Escola Nacional de Saúde Pública Sergio Arouca (ENSP/ Fiocruz), Jorge Bermudez. A atividade será mediada pela conselheira nacional de Saúde pela Associação Brasileira Superando o Lúpus, Ana Lúcia Paduello.Live Inovacao tecnologica que o Brasil precisa 1507 1280x720 Este é o 8º encontro do Comitê do CNS de acompanhamento da Covid-19 com transmissão ao vivo. Também participarão do debate a conselheira nacional de Saúde pela Conferência Nacional dos Bispos do Brasil (CNBB), Lenise Garcia, representando o segmento de usuários(as) do Sistema Único de Saúde (SUS); o conselheiro nacional de Saúde pela Confederação Nacional da Indústria (CNI), Nelson Mussolini, representando o segmento de gestores/as/prestadores/as; e o conselheiro nacional de Saúde pela Federação Nacional dos Farmacêuticos (Fenafar), Ronald dos Santos, representando o segmento de trabalhadores/as. O CNS, enquanto órgão responsável pelo controle social no SUS, tem proposto encaminhamentos e medidas, por meio de recomendações, cartas e notas, com o objetivo de atenuar os impactos do cenário atual. Recentemente, aprovou uma moção de apoio ao PL 1.462/2020, que propõe a suspensão temporária de patentes sobre toda e qualquer tecnologia em saúde que possa ser usada contra a pandemia da Covid-19.

Comparative overview of innovation and patent filings in Radiopharmacy / Panorama comparativo da inovação e do depósito de patentes em Radiofarmácia

ABSTRACT Objective To expose the current situation of the Brazilian Nuclear Medicine in relation to innovation, taking into account the Intellectual Property protection and the particularities of this field. Methods The number and the origin of patents filings from Brazil, United States and European Patent Convention countries were retrospectively compared in a 20-year period. Results The number of accumulated patents filings of conventional pharmaceuticals was ten times higher compared to the radiopharmaceuticals in the three regions studied. Conclusion The largest number of Brazilian patents filings corresponded to the international patent applications, which is related to the country development conditions, as well as to the difficulties in the process of patent filing.

RESUMO Objetivo Evidenciar a situação atual da Medicina Nuclear brasileira em relação à inovação, considerando a proteção à Propriedade Intelectual e suas particularidades na área. Métodos Foi realizado um levantamento comparativo do número e da origem de depósitos de patentes relacionadas a essa área no Brasil, nos Estados Unidos e em países participantes da European Patent Convention , em um período de 20 anos retroativos. Resultados O número de depósitos acumulados de patentes de medicamentos convencionais foi dez vezes maior quando comparado às famílias relacionadas aos processos que envolvem radiofármacos, nas três regiões estudadas. Conclusão O maior número de depósitos de patentes brasileiras correspondeu aos pedidos de patentes internacionais, refletindo as condições de desenvolvimento do país, bem como as dificuldades encontradas no processo de depósito de uma patente.

Las tres Europas ante la encrucijada genómica / The Three Europes at the genomic crossroad / Les Tres Europes enfront de la cruïlla genómica

La reciente aceleración de las investigaciones en ingeniería genética ha situado a Europa en una aporía de difícil solución. Pues bien, no queremos renunciar a determinados valores, aun cuando suponga no poder seguir el ritmo de China o de Estados Unidos; pero si no lo hacemos, corremos el riesgo de ser objeto de una forma de colonialismo muy diferente a la que hemos observado en los siglos precedentes

The recent acceleration of research in genetic engineering has placed Europe in an aporia of difficult solution. On the one hand, it is in the midst of two contending blocs, China and the United States, which in their struggle for world primacy have reissued the Cold War, only with biotechnology as a mechanism of domination. On the other, Europe is institutionally divided into three overlapping entities, the Council of Europe, the European Union and the European Patent Office, with notable differences in terms of democratic legitimacy and normative effectiveness. So, we do not want to give up certain values, even if it means not being able to keep pace with China or the United States; but if we do not, we run the risk of being the object of a form of colonialism very different from that we have observed in previous centuries

La recent acceleració de les recerques en enginyeria genètica ha situat a Europa en una aporia de difícil solució. D'una banda, es troba enmig de dos blocs contendents, la Xina i els Estats Units, en una reedició de la Guerra Freda, només que amb la biotecnologia com a mecanisme de dominació; d'un altre, Europa es troba institucionalment fraccionada en tres entitats superposades, el Consell d'Europa, la Unió Europea i l'Oficina Europea de Patents, amb diferències notables quant a legitimitat democràtica i a eficàcia normativa. Doncs bé, no volem renunciar a determinats valors, tot i que suposi no poder seguir el ritme de la Xina o dels Estats Units; però si no ho fem, correm el risc de ser objecte d'una forma de colonialisme molt diferent a la que hem observat en els segles precedents

Fuentes de información de patentes y procedimiento para las búsquedas de libertad de acción en Cuba / Patent information sources and procedure for freedom-to-operate searches in Cuba

Objetivo: proponer un procedimiento metodológico para la realización de búsquedas de libertad de acción utilizando información técnica legal de documentos de patentes. Métodos: primeramente se caracterizaron numerosas bases de datos de patentes de acceso gratuito disponibles en internet (Patentescope®, Latipat, Espacenet, Invenes, Depatisnet, Lens.org y Patentinspiration) con respecto a la cobertura temporal y a la cantidad de patentes cubanas, y se identificaron y estudiaron dos fuentes de información que recogen estados legales de estas (INPADOC y WIPO Register Portal). Resultados: Patentscope® e Invenes se consideraron como las mejores bases, ya que permiten la búsqueda en el documento completo (título, resumen, descripción y reivindicaciones) mediante palabras clave; y Depatisnet se considera útil cuando se consulta mediante el Código Internacional de Patentes reclasificado por la Oficina de Patentes Alemana. No obstante, se recomienda el uso de todas las bases estudiadas para evadir errores relacionados con los contenidos y otras limitaciones relacionadas con las facilidades de búsqueda. A partir de las prestaciones detectadas en las fuentes de información analizadas, se implementó y perfeccionó un proceso de búsqueda sobre un medicamento preventivo contra el VIH/SIDA que demostró que existía libertad de acción en Cuba para su explotación, así como también la pertinencia de las herramientas y la metodología utilizadas para realizar este tipo de búsquedas. Conclusiones: este estudio de caso permite poner en práctica un procedimiento para realizar búsquedas y evidencia la importancia de la implementación del servicio de búsqueda libertad de acción para facilitar el acceso a invenciones patentadas, especialmente en el campo médico-farmacéutico(AU)

Objective: a methodological procedure is proposed to conduct freedom-to-operate searches using patent documentation-related legal technical information. Methods: first, characterization was performed of a large number of open-access patent databases available on the Internet (Patentescope®, Latipat, Espacenet, Invenes, Depatisnet, Lens.org and Patentinspiration) with respect to time coverage and number of Cuban patents, followed by identification and analysis of two information sources referring to their legal status (INPADOC y WIPO Register Portal). Results: Patentscope® and Invenes were considered to be the best databases, since they allow to search the entire document (title, abstract, description and claims) by means of key words. Depatisnet was found to be useful for inquiries about the International Patent Classification as re-classified by the German Patent Office. However, it is recommended to use all the databases studied to avoid content-related errors and other limitations to do with search functions. Based on the possibilities offered by the information sources analyzed, a search procedure for an HIV/AIDS preventive drug was implemented and perfected, showing that there was freedom-to-operate in Cuba for its exploitation, as well as the relevance of the tools and the methodology used to perform this type of search. Conclusions: in this case study a procedure is made operational and evidence is provided of the importance of implementing the freedom-to-operate search service to facilitate access to patented inventions, especially in the medical-pharmaceutical field(AU)

Fuentes de información de patentes y procedimiento para las búsquedas de libertad de acción en Cuba / Patent information sources and procedure for freedom-to-operate searches in Cuba

Objetivo: proponer un procedimiento metodológico para la realización de búsquedas de libertad de acción utilizando información técnica legal de documentos de patentes. Métodos: primeramente se caracterizaron numerosas bases de datos de patentes de acceso gratuito disponibles en internet (Patentescope®, Latipat, Espacenet, Invenes, Depatisnet, Lens.org y Patentinspiration) con respecto a la cobertura temporal y a la cantidad de patentes cubanas, y se identificaron y estudiaron dos fuentes de información que recogen estados legales de estas (INPADOC y WIPO Register Portal). Resultados: Patentscope® e Invenes se consideraron como las mejores bases, ya que permiten la búsqueda en el documento completo (título, resumen, descripción y reivindicaciones) mediante palabras clave; y Depatisnet se considera útil cuando se consulta mediante el Código Internacional de Patentes reclasificado por la Oficina de Patentes Alemana. No obstante, se recomienda el uso de todas las bases estudiadas para evadir errores relacionados con los contenidos y otras limitaciones relacionadas con las facilidades de búsqueda. A partir de las prestaciones detectadas en las fuentes de información analizadas, se implementó y perfeccionó un proceso de búsqueda sobre un medicamento preventivo contra el VIH/SIDA que demostró que existía libertad de acción en Cuba para su explotación, así como también la pertinencia de las herramientas y la metodología utilizadas para realizar este tipo de búsquedas. Conclusiones: este estudio de caso permite poner en práctica un procedimiento para realizar búsquedas y evidencia la importancia de la implementación del servicio de búsqueda libertad de acción para facilitar el acceso a invenciones patentadas, especialmente en el campo médico-farmacéutico(AU)

Objective: a methodological procedure is proposed to conduct freedom-to-operate searches using patent documentation-related legal technical information. Methods: first, characterization was performed of a large number of open-access patent databases available on the Internet (Patentescope®, Latipat, Espacenet, Invenes, Depatisnet, Lens.org and Patentinspiration) with respect to time coverage and number of Cuban patents, followed by identification and analysis of two information sources referring to their legal status (INPADOC y WIPO Register Portal). Results: Patentscope® and Invenes were considered to be the best databases, since they allow to search the entire document (title, abstract, description and claims) by means of key words. Depatisnet was found to be useful for inquiries about the International Patent Classification as re-classified by the German Patent Office. However, it is recommended to use all the databases studied to avoid content-related errors and other limitations to do with search functions. Based on the possibilities offered by the information sources analyzed, a search procedure for an HIV/AIDS preventive drug was implemented and perfected, showing that there was freedom-to-operate in Cuba for its exploitation, as well as the relevance of the tools and the methodology used to perform this type of search. Conclusions: in this case study a procedure is made operational and evidence is provided of the importance of implementing the freedom-to-operate search service to facilitate access to patented inventions, especially in the medical-pharmaceutical field(AU)